K Number

Device Name

AltiVate Reverse Humeral Stem, 48mm

Manufacturer

Encore Medical, L.P.

Date Cleared

2019-04-26

(74 days)

Product Code

KWS HSD

Regulation Number

888.3660

Intended Use

Anatomic Total Shoulder Indications: The AltiVate Reverse Humeral Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: - · Noninflammatory degenerative joint disease including osteoarthritis; - · Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis; - · Post-traumatic arthritis of the glenohumeral joint; - · Avascular necrosis of the humeral head with and without involvement of the glenoid; - · Correction of functional deformity The all-poly glenoid is intended for cemented use Hemi Shoulder Indications: The AltiVate Reverse Humeral Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to: - · Noninflammatory degenerative joint disease including osteoarthritis; - · Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; - · Post-traumatic arthritis of the glenohumeral joint; - · Avascular necrosis of the humeral head with and without involvement of the glenoid; - · Correction of functional deformity; - · Rotator cuff tear arthropathy; - · Humeral fracture. - · Failed previous shoulder surgery Reverse Total Shoulder Indications: The AltiVate Reverse Humeral Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: - · Severe arthropathy with a grossly deficient rotator cuff; - · Previously failed joint replacement with a grossly deficient rotator cuff; - · Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; - · Bone defect in proximal humerus; • Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/ or glenoid; - · Inflammatory arthritis including rheumatoid arthritis; - · Correction of functional deformity. The glenoid baseplate is intended for cementless application of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures All humeral stems are intended for cemented or cementless use.

Device Description

The AltiVate Reverse® Humeral Shoulder Stem is a single component manufactured from wrought forged titanium alloy. The stem distal body is cylindrical with four flutes. The stem's body flares proximally to a trapezoidal cross-sectional midbody, and a hemispherical shell is most superior. The stem has porous coating applied on, and around, the outer spherical diameter of the shell. Porous coating is applied, under the shell, to the stem's medial, anterior, and posterior surfaces. Two fins are located in symmetry on the stem's antero-lateral and mediolateral midbody corners to promote shoulder humeral fracture tuberosity reduction to providing rotational stability. The fins protrude at 45° from the frontal plane. Each fin has two suture holes for reattachment of soft tissue or bone fragments in cases of proximal humeral fracture. A larger hole is located under the stem's shell which traverses the stem body through the medial-lateral plane to allow through a cerclage wire or suture anchorage point. Four suture holes are located through the stem's shell to aid in soft tissue reattachment and fractured shoulder tuberosity reduction. A larger hole spans the stem's midbody within the medial-lateral plane. The hole is tapered to maintain constant stem wall thickness without compromising fatigue strength. This hole can be used for temporary or long-term bone graft fixation in addition to soft-tissue reattachment. Three slots are located through the stem's shell: anterior, posterior, and medial. These slots allow surgical access by osteotome, or other instruments, for stem removal and separation from bone during revision surgery. A central screw thread within the stem's shell allows mating interface with other surgical instruments or implants.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K141990, K162024, K172351, K122698, K113413

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical implant (humeral stem) and its indications for use. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical testing and comparisons to predicate devices.

Therapeutic

Yes
The device is a joint replacement used to treat pain and dysfunction caused by various conditions like arthritis, avascular necrosis, or fractures, thereby restoring function and alleviating symptoms.

Diagnostic

This device is described as an artificial Humeral Stem intended for joint replacement, which is a therapeutic device, not a diagnostic one. Its purpose is to treat pain and dysfunction, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly details a physical implantable medical device (humeral stem) made of titanium alloy with specific physical features and intended for surgical implantation. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Description: The description clearly states that the AltiVate Reverse Humeral Stem is a physical implant made of titanium alloy, designed to replace a shoulder joint.
Intended Use/Indications for Use: The indications describe conditions of the shoulder joint that require surgical intervention and replacement, not diagnostic testing.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.

This device is a surgical implant intended for the treatment of various shoulder conditions through joint replacement.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Anatomic Total Shoulder Indications:

The AltiVate Reverse Humeral Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral joint;
· Avascular necrosis of the humeral head with and without involvement of the glenoid;
· Correction of functional deformity

The all-poly glenoid is intended for cemented use

Hemi Shoulder Indications:

The AltiVate Reverse Humeral Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral joint;
· Avascular necrosis of the humeral head with and without involvement of the glenoid;
· Correction of functional deformity;
· Rotator cuff tear arthropathy;
· Humeral fracture.
· Failed previous shoulder surgery

Reverse Total Shoulder Indications:

The AltiVate Reverse Humeral Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

· Severe arthropathy with a grossly deficient rotator cuff;
· Previously failed joint replacement with a grossly deficient rotator cuff;
· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
· Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/ or glenoid;
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity.

The glenoid baseplate is intended for cementless application of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.

All humeral stems are intended for cemented or cementless use.

Product codes (comma separated list FDA assigned to the subject device)

KWS, HSD

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, humeral head, glenoid

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing: Mechanical testing was previously completed and submitted with K141990 and K172351. Evaluations of this testing as compared to the subject device determined that the previous testing could be applied to the subject device. Testing included porous coating surface area evaluation and dimensional comparisons.

No mechanical testing was performed on the subject device humeral stems and that engineering rationale was used to compare the subject device humeral stems to the predicate devices K172351,K162024,and K122698.

All evaluations determined that the device is substantially equivalent to the predicate devices.

Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.

Clinical Testing: Clinical testing was not required

Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141990, K162024, K172351, K122698, K113413

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Summary

Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758

Re: K190290

Trade/Device Name: AltiVate Reverse Humeral Stem, 48mm Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: March 26, 2019 Received: March 28, 2019

Dear Teffany Hutto:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

April 26, 2019

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2019.04.26 15:50:07 -04'00'

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K190290

Device Name

AltiVate Reverse® Humeral Stem, 48mm

Indications for Use (Describe)

Anatomic Total Shoulder Indications:

The AltiVate Reverse Humeral Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral joint;
· Avascular necrosis of the humeral head with and without involvement of the glenoid;
· Correction of functional deformity

The all-poly glenoid is intended for cemented use

Hemi Shoulder Indications:

The AltiVate Reverse Humeral Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral joint;
· Avascular necrosis of the humeral head with and without involvement of the glenoid;
· Correction of functional deformity;
· Rotator cuff tear arthropathy;
· Humeral fracture.
· Failed previous shoulder surgery

Reverse Total Shoulder Indications:

· Severe arthropathy with a grossly deficient rotator cuff;
· Previously failed joint replacement with a grossly deficient rotator cuff;
· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture,

displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;

· Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/ or glenoid;
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity.

All humeral stems are intended for cemented or cementless use.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date: April 24, 2019

Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto(@djoglobal.com

| Product | Common Name | Classification | Product
Code |
|--------------------------------------------------|------------------------|----------------|-----------------|
| AltiVate Reverse® Humeral
Shoulder Stem, 48mm | Total Shoulder Implant | Class II | KWS, HSD |

| Product

Code	Regulation and Classification Name
KWS	Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660
HSD	Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis per CFR
888.3690

Description:

Indications for Use:

Anatomic Total Shoulder Indications:

The AltiVate Reverse Humeral Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral ioint:
· Avascular necrosis of the humeral head with and without involvement of the glenoid;
· Correction of functional deformity

The all-poly glenoid is intended for cemented use.

Hemi Shoulder Indications:

The AltiVate Reverse Humeral Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis;
· Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
· Post-traumatic arthritis of the glenohumeral joint;
· Avascular necrosis of the humeral head with and without involvement of the glenoid:
· Correction of functional deformity:
Rotator cuff tear arthropathy:
Humeral fracture;
· Failed previous shoulder surgery.

Reverse Total Shoulder Indications:

· Severe arthropathy with a grossly deficient rotator cuff;
· Previously failed joint replacement with a grossly deficient rotator cuff;

· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection:

· Bone defect in proximal humerus;
· Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity.

All humeral stems are intended for cemented or cementless use.

Predicate Devices:

AltiVate Reverse® Humeral Stem, DJO Surgical K141990 ●
AltiVate Anatomic® Shoulder System, DJO Surgical K162024 ●
AltiVate Reverse® Small Shell, DJO Surgica1 K172351 ●
Aequalis Ascend Flex Shoulder System, Wright/Tornier K122698 ●
Aequalis, Wright/Tornier K113413 ●

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications for use, same features and principals of operation, same implant material, same porous coating material, same sterilization, packaging, and shelf life, same compatible components. Differences to the predicates include the additional size offering of the 48mm stem.

All evaluations determined that the device is substantially equivalent to the predicate devices.

Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.

Clinical Testing: Clinical testing was not required

Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.